Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations As explained in the preamble to the proposed rule, VA policy and practice regarding CLIA compliance was developed in consultation with HHS in 1994 and 1998. Additionally, in 2000, after further consultation, VA and CMS
entered into an interagency agreement IAA, which documented the history of the parties consultations and agreements and granted VA limited authority to act on behalf of CMS.
In 2018, CMS and VA met to begin the process to review and update the 2010
agreement and it was proposed to replace the IAA with a memorandum of understanding MOU, and to review and renew every six years thereafter.
The IAA was converted to an MOU and approved on May 22, 2020. In addition, CMS and VA agreed to meet annually to discuss program issues of mutual importance.
To ensure VA operated laboratories remain current with CMS CLIA
requirements, VA participates in the CMS Partners in Laboratory Oversight group, consults with CMS as needed, and participates in at least one formal consultative meeting per year.
Additionally, VA provides updated data to CMS for each VA laboratory assigned a CLIA number at least every two years, or as changes occur. Furthermore, VA
provides CMS with any requested information regarding the operation and performance of VA laboratories and the operations of the oversight program.
This final rulemaking formalizes VAs application of the CLIA requirements to VA laboratory operations by adding a new section 17.3500 to 38 CFR, VA
application of 42 CFR part 493
standards for clinical laboratory operations, to its medical regulations.
Section 17.3500 addresses CLIA
regulations found at 42 CFR part 493, by subpart, and how VA will apply those regulations. This rule will also allow VA
to continue to assure that medical facility laboratories across our system perform and report out consistent, accurate, and reliable laboratory testing, ensuring the provision of quality testing for our patients in a manner comparable to non-VA laboratories.
In response to the proposed rule, VA
received four comments. One commenter expressed support for the rule, and we thank the commenter for supporting the rule.
Another commenter noted a grammatical error in the preamble but did not suggest any edits be made to the rule. Specifically, the commenter noted that in the first paragraph of the Supplemental Information section, we referred to the definition of laboratory or clinical laboratory found at 42
U.S.C. 263aa and quoted from that
VerDate Sep<11>2014

16:08 May 06, 2021

Jkt 253001

statutory definition without using quotation marks. The commenter is correct, however no change in the regulatory text is needed. We are not making any edits to this rulemaking based on this comment, and we thank the commenter for their feedback.
Another commenter provided the same comment twice. The comment was supportive of the rule, but provided multiple recommendations regarding:
1 Personnel requirements; 2 scope of practice; and 3 accreditation organizations. The commenter also attached a comment that was submitted to CMS in March 2018 in response to a request for information. In this rulemaking, we will only address the comment that was directed to VA and will not address the comment directed to CMS.
1. Personnel Requirements. The commenter raised concerns over the academic and clinical training requirements for high complexity laboratory personnel to broaden the potential labor force of laboratory professionals while simultaneously ensuring they are properly qualified to provide high quality testing. The commenter recommended that we modify the CLIA personnel requirements to: 1 Allow an earned baccalaureate degree with at least 30
hours or equivalent of coursework in biological and chemical sciences appropriate to a major in one of these sciences to satisfy the academic degree requirement; 2 clarify that all high complexity testing personnel must complete clinical training, either from an accredited clinical training program or documented laboratory training prior to testing patient samples; 3 create personnel standards for histotechnology professionals, requiring that they complete an associate degree or equivalent in the chemical or biological sciences, and complete either an accredited or structured training program under the auspices of a board certified pathologist or designee; and 4
require all high complexity laboratory personnel to pass a national certification examination.
The purpose of this rulemaking is to fulfill the requirements of section 101 of Public Law 102139 for rules equal to those applicable to other medical facility laboratories subject to the CLIA
requirements as implemented under the Public Health Service Act . As previously stated, CMS implemented CLIA regulations at 42 CFR part 493, and VA is amending its medical regulations to incorporate those portions of 42 CFR part 493 as adopted by VA.
Personnel requirements for performing non-waived testing are addressed in
PO 00000

Frm 00013

Fmt 4700

Sfmt 4700

24495

subpart M of 42 CFR part 493, and VA
will apply all standards from this subpart except the requirements to maintain a license in the state where the laboratory is located. In other words, in formalizing VAs application of the CLIA requirements implemented by CMS, VA cannot adopt less rigorous standards than those of CMS.
While VA cannot adopt less rigorous standards, if deemed necessary, VA will further delineate higher personnel qualifications in policy. For example, VA currently maintains a higher personnel qualification standard for medical technologists in policy. Medical technologists are required to possess a combination of a bachelors degree, or higher, and clinical practice experience.
Additionally, medical technologists must possess, or obtain within one year from date of appointment, an appropriate certification from the American Society for Clinical Pathology or the American Medical Technologists.
Furthermore, in areas where VA has not implemented a more rigorous standard than CMS, it is because we believe their standards satisfy our specific needs and ensure the safety, efficiency, and reliability of our laboratories. Like all public institutions, VA must balance the goals of verifying staff competency with creating a flexible enough barrier to entry that we can attract the best minds from all areas of clinical laboratory science.
We are not making any changes to this rulemaking based on this comment.
2. Scope of Practice. The commenter sought to confirm their interpretation that this rule does not impact the scope of practice for advanced practice registered nurses APRNs to order laboratory and imaging studies and integrate the results into clinical decision making, but not to perform or interpret any laboratory test. The commenter also urged the VA to maintain this policy.
The commenter is correct that this rule does not impact APRN scope of practice. In a document published in the Federal Register on May 25, 2016, VA
proposed to amend its regulation to permit full practice authority of four types of APRNs. 81 FR 33155. Proposed 38 CFR 17.415d1iB stated in part that a certified nurse practitioner CNP
may order, perform, or supervise laboratory and imaging studies. Several commenters were concerned with the language, and VA agreed with commenters that the language may be construed as allowing CNPs to perform laboratory studies. In a document published in the Federal Register on December 14, 2016, VA published its final rulemaking and amended
E:FRFM07MYR1.SGM

07MYR1